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临床试验/CTRI/2022/06/042995
CTRI/2022/06/042995已完成不适用

A synopsis on Assessment of Likelihood Ratio of four symptoms of Medorrhinum in Patients of Osteoarthritis.

National Institute of Homoeopathy1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6月13日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Numeric rating scale measuring intensity of pain. ‘0’ being ‘no pain’ and ‘10’ being ‘worst pain imaginable’. The patient picks or draws a circle around the number that best describes the pain intensity.

研究概览

简要总结

The patient’s information shall be recorded in a standardized case taking proforma used in NIH, Kolkata (Appendix). Following preliminary screening for osteoarthritis and detailed screening using specified selection (inclusion and exclusion) criteria of the screening proforma (Appendix), eligible patients will be included in the study, followed by recording of baseline scoring data.  All eligible patients suffering from osteoarthritis, symptoms will be first matched prospectively with any of the four osteoarthritic symptoms of Medorrhinum. If similarities are detected, they will be prescribed with Medorrhinum. Otherwise, the patients were prescribed with other homoeopathic medicines as per indications. Though final selection of the medicine will be based on case taking in adherence with the standard homoeopathic guidelines, analysis and evaluation of symptoms, miasmatic diagnosis, framing symptom totality, and final conclusion with Homoeopathic Materia Medica (Appendix). Individualized dose will be selected on the basis of susceptibility of the patients. Subsequent prescriptions will be generated according to Kent’s observations, second prescription and relevant homoeopathic principles and will be recorded in follow-up sheets (Appendix). Again the scoring data will be recorded 3 months and 6months after treatment.

研究设计

研究类型
Interventional

入排标准

年龄范围
35.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients suffering from osteoarthritis of any joint verified by clinical examination and X-Ray.
  • Patient aged 35-75 year, both male and female.
  • Subjects of all socio-economic status, all religions.
  • Patients giving written consent to participate in this study.
  • Subjects who agree to comply with the protocol.
  • Subjects who agree to undergo laboratory investigation whenever required.

排除标准

  • Patients below the age of 35 years.
  • Patients with increased serum uric acid level, or positive rheumatoid factors or any clinical evidence of psoriatic arthritis.
  • Patients with unstable psychiatric disorder.
  • Pregnant or lactating women.
  • Immune compromised state.
  • Substance abuse and/or dependence.
  • Uncontrolled hypertension, diabetes or any other systemic illness or life-threatening diseases.
  • Cases already undergoing homoeopathic treatment for any chronic illness.
  • Unwilling to participate or to comply with the study requirements, too unwell to take part, or declined to provide consent.

结局指标

主要结局

Numeric rating scale measuring intensity of pain. ‘0’ being ‘no pain’ and ‘10’ being ‘worst pain imaginable’. The patient picks or draws a circle around the number that best describes the pain intensity.

时间窗: Baseline 3 months 6 months

次要结局

  • EQ-5D-5L questionnaire is a quality of life questionnaire. It is used for evaluating the health status and stability of the patient. Consists of 2 pages- the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ VAS). The descriptive system comprises 5 dimensions- mobility, self care, usual activities, pain/discomfort, anxiety/depression.(Baseline, 3 months, 6 months)

研究者

申办方类型
Government medical college

研究点 (1)

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